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New treatment option for Acute Promyelocytic Leukemia With PML-RARA
Official title Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
ClinicalTrials.gov ID: NCT01409161
What this study is testing
What is Arsenic Trioxide?
Arsenic Trioxide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute promyelocytic leukemia with pml-rara.
Also referred to as Arsenic (III) Oxide, Arsenic Sesquioxide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 and older
You may be able to join if
- A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test
- Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of...
- Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or...
- Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at...
- All sexually active people (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the...
You likely can't join if
- Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds
- Patients with creatinine \> 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis...
- Patients with total bilirubin \>= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or...
- Patients with alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 3 times upper limit of normal unless felt to be related the...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Nassau Bay, Texas, United States
- Sugar Land, Texas, United States
- The Woodlands, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Nassau Bay, Texas, United States; Sugar Land, Texas, United States; The Woodlands, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.